CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones

• Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System (Device): The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).

Primary outcomes

• Stone Clearance (% Reduction in Stone Volume) [30 Days]: The percent reduction (\[Baseline stone volume- 30-Day stone volume\] / Baseline stone volume) in stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness). A positive result indicates a decrease in stone volume removed during the procedure; a negative value indicates an increase in stone volume following the procedure.
• Residual Stone Volume (RSV) [30 Days]: A continuous quantitative measure of remaining stone volume following intervention, observed on non-contrast CT (NCCT) (2.0mm slice thickness).
• Stone Free Rate (SFR) - Zero Fragments [30 Days]: Where stone free status is defined as zero residual fragments at 30 days observed on non-contrast CT (NCCT) (2.0mm slice thickness). SFR is calculated by determining the number of kidneys in each treatment arm with a stone free status of zero fragments and dividing that by the total number of kidneys treated in the respective treatment arm.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Candidate for ureteroscopy with laser lithotripsy;
* Be willing and able to return for and respond to all study-related follow up procedures; and,
* Have been informed of the nature of the study and have agreed to the IRB approved informed consent form (ICF).

Exclusion Criteria:

* Significant morbidities;
* Unable to meet the treatment and follow up protocol requirements; and,
* Ureteral or kidney abnormalities.

Participant flow

Outcome results

• Stone Clearance (% Reduction in Stone Volume) (Primary), Mean, % stone volume removed: Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System 96.2 +/- 6.5
• Residual Stone Volume (RSV) (Primary), Mean, mm^3: Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System 14.1 +/- 23.0
• Stone Free Rate (SFR) - Zero Fragments (Primary), Count of units, kidneys: Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC System 13

Adverse events

Time frame: Index Procedure to Post-op Day-30 (POD30)

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2023-11-08)